Australia Therapeutic Goods (Medical Devices) Regulations 2002 r8AA: Healthcare facilities (hospitals and day hospitals): report to the TGA electronically adverse events involving Class III and Class 4 IVD devices within 10 days of a death or serious deterioration and within 45 days of a related intervention or treatment, with the facility's healthcare identifier and the event details

What does r8AA require?

Under section 41JM of the Act, as prescribed in Part 8AA (added by the UDI and Other Measures Regulations 2025, commenced 21 March 2026), the chief executive of a healthcare facility (including a day-hospital facility) must report adverse events involving reportable medical devices, namely Class III devices and Class 4 IVDs. The report must include the facility's healthcare identifier, the date of use and the date of death or of first identifying the serious deterioration with its nature, the date of any intervention or treatment and the nature of the deterioration, and the manufacturer's name if known. It must be given within 10 days of the death or of identifying the deterioration, or within 45 days of the intervention or treatment, in an electronic form (not fax or a scanned document).